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冠状动脉左主干病变PCI或CABG后的5年结局比较
Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease


Gregg W. Stone ... 心脑血管疾病 • 2019.11.07
相关阅读
• 依维莫司洗脱支架和旁路术治疗冠状动脉左主干病变的比较研究 • 冠状动脉左主干支架置入术与旁路术相比具有非劣效性

中低危无保护左主干病变中PCI与CABG再次对决

 

郑博,霍勇*

北京大学第一医院心内科

*通讯作者

 

在2019年9月底结束的TCT 2019大会上,Gregg Stone教授公布的EXCEL研究5年随访研究,再次将无保护左主干治疗的话题推向风口浪尖1。3年前,同样在TCT大会上,EXCEL研究3年随访和NOBLE研究5年随访结果大相径庭2,3。因此,大家都期待在当代支架系统、手术操作技术以及药物治疗理念下,两种治疗手段究竟孰优孰劣。

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摘要


背景

冠状动脉左主干病变患者接受当代药物洗脱支架经皮冠状动脉介入治疗(PCI)与接受冠状动脉旁路移植术(CABG)后的长期结局尚未明确。

 

方法

我们将解剖结构复杂程度(根据各参与中心的评估结果)低或中等的1,905例冠状动脉左主干病变患者随机分组,分别接受含氟聚合物涂层钴铬合金依维莫司洗脱支架PCI(PCI组,948例患者)或CABG(CABG组,957例患者)治疗。主要结局是由死亡、卒中或心肌梗死构成的复合结局。

 

结果

5年时,PCI组22.0%的患者和CABG组19.2%的患者发生了主要结局事件(差异,2.8个百分点;95%置信区间[CI],0.9~6.5;P=0.13)。PCI组的全因死亡率高于CABG组(13.0% vs. 9.9%;差异,3.1个百分点;95% CI,0.2~6.1)。在PCI组和CABG组中,明确心血管原因死亡率(分别为5.0%和4.5%;差异,0.5个百分点;95% CI,-1.4~2.5)和心肌梗死发生率(10.6%和9.1%;差异,1.4个百分点;95% CI,-1.3~4.2)无显著差异。PCI后的所有脑血管事件发生率均低于CABG后(3.3% vs. 5.2%;差异,-1.9个百分点;95% CI,-3.8~0),但两组的卒中发生率无显著差异(2.9%和3.7%;差异,-0.8个百分点;95% CI,-2.4~0.9)。PCI后缺血驱动的血运重建发生率高于CABG后(16.9% vs. 10.0%;差异,6.9个百分点;95% CI,3.7~10.0)。

 

结论

在解剖结构复杂程度低或中等的冠状动脉左主干病变患者中,在5年时由死亡、卒中或心肌梗死构成的复合结局发生率方面,PCI和CABG之间无显著差异(由Abbott Vascular资助;EXCEL在ClinicalTrials.gov注册号为NCT01205776)。





作者信息

Gregg W. Stone, M.D., A. Pieter Kappetein, M.D., Ph.D., Joseph F. Sabik, M.D., Stuart J. Pocock, Ph.D., Marie-Claude Morice, M.D., John Puskas, M.D., David E. Kandzari, M.D., Dimitri Karmpaliotis, M.D., W. Morris Brown, III, M.D., Nicholas J. Lembo, M.D., Adrian Banning, M.D., Béla Merkely, M.D., Ferenc Horkay, M.D., Piet W. Boonstra, M.D., Ad J. van Boven, M.D., Imre Ungi, M.D., Gabor Bogáts, M.D., Samer Mansour, M.D., Nicolas Noiseux, M.D., Manel Sabaté, M.D., Jose Pomar, M.D., Mark Hickey, M.D., Anthony Gershlick, M.D., Pawel E. Buszman, M.D., Andrzej Bochenek, M.D., Erick Schampaert, M.D., Pierre Pagé, M.D., Rodrigo Modolo, M.D., Ph.D., John Gregson, Ph.D., Charles A. Simonton, M.D., Roxana Mehran, M.D., Ioanna Kosmidou, M.D., Philippe Généreux, M.D., Aaron Crowley, M.A., Ovidiu Dressler, M.D., and Patrick W. Serruys, M.D., Ph.D. for the EXCEL Trial Investigators*
From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke’s (J. Puskas), and New York–Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) — all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) — all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) — all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) — both in Hungary; Centre Hospitalier de l’Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron — both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.). Address reprint requests to Dr. Stone at the Cardiovascular Research Foundation, 1700 Broadway, 8th Fl., New York, NY 10019, or at gstone@crf.org. *A complete list of investigators, institutions, and research organizations participating in the EXCEL trial is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Morice MC, Serruys PW, Kappetein AP, et al. Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Trial. Circulation 2014;129:2388-2394.

2. Stone GW, Sabik JF, Serruys PW, et al. Everolimus-eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med 2016;375:2223-2235.

3. Mäkikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet 2016;388:2743-2752.

4. Palmerini T, Serruys P, Kappetein AP, et al. Clinical outcomes with percutaneous coronary revascularization vs coronary artery bypass grafting surgery in patients with unprotected left main coronary artery disease: a meta-analysis of 6 randomized trials and 4,686 patients. Am Heart J 2017;190:54-63.

5. Laukkanen JA, Kunutsor SK, Niemelä M, Kervinen K, Thuesen L, Mäkikallio TH. All-cause mortality and major cardiovascular outcomes comparing percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: a meta-analysis of short-term and long-term randomised trials. Open Heart 2017;4(2):e000638-e000638.

6. Fihn SD, Blankenship JC, Alexander KP, et al. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2014;64:1929-1949.

7. Patel MR, Calhoon JH, Dehmer GJ, et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol 2017;69:2212-2241.

8. Windecker S, Neumann FJ, Jüni P, Sousa-Uva M, Falk V. Considerations for the choice between coronary artery bypass grafting and percutaneous coronary intervention as revascularization strategies in major categories of patients with stable multivessel coronary artery disease: an accompanying article of the task force of the 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019;40:204-212.

9. Kappetein AP, Serruys PW, Sabik JF, et al. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial. EuroIntervention 2016;12:861-872.

10. SYNTAX score calculator (http://ir-nwr.ru/calculators/syntaxscore.htm. opens in new tab).

11. Little RJ, D’Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012;367:1355-1360.

12. Royston P, Parmar MK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol 2013;13:152-152.

13. Collet C, Capodanno D, Onuma Y, et al. Left main coronary artery disease: pathophysiology, diagnosis, and treatment. Nat Rev Cardiol 2018;15:321-331.

14. Bittl JA, He Y, Jacobs AK, Yancy CW, Normand SL. Bayesian methods affirm the use of percutaneous coronary intervention to improve survival in patients with unprotected left main coronary artery disease. Circulation 2013;127:2177-2185.

15. Baron SJ, Chinnakondepalli K, Magnuson EA, et al. Quality-of-life after everolimus-eluting stents or bypass surgery for left-main disease: results from the EXCEL Trial. J Am Coll Cardiol 2017;70:3113-3122.

16. Stolker JM, Spertus JA, Cohen DJ, et al. Rethinking composite end points in clinical trials: insights from patients and trialists. Circulation 2014;130:1254-1261.

17. Arnold SV, Magnuson EA, Wang K, et al. Do differences in repeat revascularization explain the antianginal benefits of bypass surgery versus percutaneous coronary intervention? Implications for future treatment comparisons. Circ Cardiovasc Qual Outcomes 2012;5:267-275.

18. Kazi DS, Hlatky MA. Repeat revascularization is a faulty end point for clinical trials. Circ Cardiovasc Qual Outcomes 2012;5:249-250.

19. Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2014;63:299-307.

20. Bangalore S, Kumar S, Fusaro M, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation 2012;125:2873-2891.

21. Head SJ, Milojevic M, Daemen J, et al. Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. Lancet 2018;391:939-948.

22. Thuijs DJFM, Kappetein AP, Serruys PW, et al. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet 2019 September 2 (Epub ahead of print).

23. Head SJ, Milojevic M, Daemen J, et al. Stroke rates following surgical versus percutaneous coronary revascularization. J Am Coll Cardiol 2018;72:386-398.

24. Palmerini T, Della Riva D, Biondi-Zoccai G, et al. Mortality following nonemergent, uncomplicated target lesion revascularization after percutaneous coronary intervention: an individual patient data pooled analysis of 21 randomized trials and 32,524 patients. JACC Cardiovasc Interv 2018;11:892-902.

25. Walsh MN, Bove AA, Cross RR, et al. ACCF 2012 health policy statement on patient-centered care in cardiovascular medicine: a report of the American College of Cardiology Foundation Clinical Quality Committee. J Am Coll Cardiol 2012;59:2125-2143.

26. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Circulation 2012;126:2020-2035.

27. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). Circulation 2018;138(20):e618-e651.

28. Moussa ID, Klein LW, Shah B, et al. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol 2013;62:1563-1570.

29. Ben-Yehuda O, Chen S, Redfors B, et al. Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial. Eur Heart J 2019;40:1930-1941.

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